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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ75104
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the pta balloon dilatation catheter was used in a left av graft and was inflated to approximately 18 atm.It was further reported that the balloon was removed from the patient and place in the back table for further use.During preparation, the technologist allegedly identified the fibers of the balloon had unraveled.Reportedly, another pta dilatation balloon was used to complete the procedure.There was no patient injury reported.
 
Manufacturer Narrative
H10: manufacturing review:the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event investigation summary:the device was returned for evaluation.A visual inspection found peeled outer layer from the balloon throughout the length of the balloon.Additionally, fibers were noted to be unraveled from the balloon on the distal cone of the balloon.Fiber disturbance was also noted on the distal end of the balloon.Therefore, the investigation was confirmed for the reported unraveled fibers, as well as for frayed fibers.Additionally, the investigation was confirmed for peeled outer layer.The definitive root cause for the identified fiber issues or outer layer peeling could not be determined based upon the available information.An investigation was currently open to address the outer layer peeling issue.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4, d4 (expiration date: 11/2020).
 
Event Description
It was reported that the pta balloon dilatation catheter was used in a left av graft and was inflated to approximately 18 atm.It was further reported that the balloon was removed from the patient and place in the back table for further use.During preparation, the technologist allegedly identified the fibers of the balloon had unraveled.Reportedly, another pta dilatation balloon was used to complete the procedure.There was no patient injury reported.
 
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Brand Name
CONQUEST PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
parque industrial colonial
tempe AZ 85281
MDR Report Key7513076
MDR Text Key108249692
Report Number2020394-2018-00670
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741063220
UDI-Public(01)00801741063220
Combination Product (y/n)N
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCQ75104
Device Catalogue NumberCQ75104
Device Lot NumberREBY2402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
Patient Weight103
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